Kornimate/medical-research-clean huggingface dataset:
optimizing electroconvulsive therapy for depression

Conditions: Depression; Depressive Disorder; Bipolar Disorder

Summary: this study will evaluate the effectiveness of electroconvulsive therapy (ect) administered with medication for the treatment of a major depressive episode (unipolar or bipolar) and will compare two types of ect.

this study addresses 2 issues in the optimization of ect in patients with major depression: whether patients treated with ect should receive concurrent treatment with antidepressant medications, and the relative efficacy and side effects of high dosage right unilateral (rul) ect compared to low dosage bilateral (bl) ect. this study has 2 phases. in phase i, patients are randomized to receive nortriptyline, venlafaxine (effexor), or placebo while they simultaneously receive either high dosage rul ect or low dosage bl ect. patients have an electrocardiogram (ekg), a chest x-ray, medical and neurological examinations, and blood tests. memory function is assessed before and after ect. whenever feasible, patients are withdrawn from all prior psychotropic medication before the start of ect. ect is administered 3 times per week to inpatients and twice a week to outpatients. patients continue ect until they are asymptomatic or until there is a plateau in improvement over 2 treatments. patients who respond to ect enter phase ii and add lithium to either nortriptyline or venlafaxine within 1-3 days of the last ect. clinical and side effect evaluations and blood level determinations are conducted weekly for the first month, every 2 weeks until week 12, and every 4 weeks for the remaining 12 weeks. following any indication of relapse, patients are monitored more intensively and are re-evaluated within 1 week. the neurocognitive battery is readministered to all patients at 2 and 6 months after the acute ect course, regardless of ect clinical outcome.

Eligibility criteria:
inclusion criteria: * major depressive episode (unipolar or bipolar) * pre-ect score of 20 or higher on hamilton rating scale for depression * able to withdraw psychotropic drugs (up to 3 mg/day lorazepam allowed) * ect indicated exclusion criteria: * schizophrenia, schizoaffective disorder, or other psychosis * amnestic disorder, dementia, or delirium * pregnancy * epilepsy * current alcohol or substance abuse or dependence * cns disease or brain injury not associated with psychotropic drug exposure * ect in the past 6 months * medical contraindication for treatment with either nortriptyline or venlafaxine, including allergy to amitriptyline, nortriptyline, or venlafaxine; narrow angle glaucoma; sinus node disease; bundle branch disease; myocardial infarction; coronary artery bypass or angioplasty; or angina * type i antiarrhythmic medication * supine blood pressure \>= 170 mmhg systolic or \>= 105 mmhg diastolic at 3 readings over 2 days

Keywords: electroconvulsive therapy antidepressive agents
clinical trial to evaluate the safety and efficacy of agr tablet as a treatment of perennial allergic rhinitis in korean

Conditions: Allergic Rhinitis; Perennial Allergic Rhinitis; Non-seasonal Allergic Rhinitis

Summary: the purpose of this study is to evaluate treatment of perennial allergic rhinitis in korean patients with agr tablet.


Eligibility criteria:
inclusion criteria * males or females no younger than 12 years. * patient with a history of perennial allergic rhinitis for at least an year. * patient with a positive prick test performed on the same day or within one year before the inclusion date.patients had to have a (+) prick test for some allergen responsible for non-seasonal rhinitis. * patients with a total symptom score before the study of 5 or greater for nasal symptoms only, assessed during inclusion visit. * patients able to attend the required number of visits. * a normal ecg. exclusion criteria * patients with non-allergic rhinitis. * patients with obstructive nasal polyps or significant deviation of nasal septum in the investigator's criterion. * known hypersensitivity to tested drugs(or similar structure) or any components of the tested drugs. * asthmatic patients who had experienced an acute clinical attack in the three months previous to the inclusion or who had received or were receiving any type of drug for its prevention or treatment. * patients receiving desensitization treatment for any perennial allergen at the inclusion time. however, inclusion of subject stopping this treatment during the study period was permitted. * failure to pass properly the washout period of the following period.

Keywords: allergic rhinitis perennial allergic rhinitis non-seasonal allergic rhinitis par
comparison of retinal oxygenation and retinal vessel diameters in healthy subjects and patients with diabetic retinopathy or retinal vein occlusion between dva and oxymap

Conditions: Healthy Subjects; Diabetic Retinopathy; Retinal Vein Occlusion

Summary: to date two different instruments are commercially available to measure retinal oxygen saturation and retinal vessel diameters: dynamic vessel analyzer (dva) and oxymap. retinal oxygen saturation analysis is based on spectroscopic evaluation of retinal fundus images. up to now no data comparing both instruments for the measurement of retinal oxygen saturation and vessel diameter are available in the literature. study objectives: to compare retinal oxygenation and retinal vessel diameters in healthy subjects and patients with diabetic retinopathy or retinal vein occlusion between 2 commercially available systems (dva, oxymap t1) study design: open pilot study study population: 30 healthy volunteers, age 18-80 years 30 type 2 diabetic patients with mild or moderate non-proliferative diabetic retinopathy, age 18-80 years 30 patients with retinal vein occlusion, age 18-80 years topically administered medication: tropicamide (mydriaticum "agepha"®, agepha, vienna, austria), dose: 1-2 drops per study day for dilation of the pupil oxybuprocainhydrochloride combined with sodium fluorescein (thilorbin®, alcon pharma gmbh, freiburg, germany), dose: 1 drop in one eye for measurements of intraocular pressure nonylacidvanillylamide combined with nicotinic-acid--ß-butoxyethylester (finalgon®, boehringer ingelheim rcv gmbh \& co kg, vienna, austria): topical on the earlobe methods: dynamic vessel analyzer oxymap t1 blood pressure and pulse rate measurement applanation tonometry oxygen and carbon dioxide partial pressure measurement in arterialized blood from earlobe main outcome variables: difference of oxygen saturation of retinal vessels between dva and oxymap t1 the motive for this investigation is to compare data between 2 commercially available instruments for the measurement of retinal oxygen saturation and retinal vessel diameter in healthy subjects as well as in patients with ocular disease associated with altered retinal oxygenation. comparative data from both systems are currently not available. data from this study will allow the comparison of studies performed with different systems. all oxygen measurement procedures are non-invasive and painless. hence, the risk/benefit ratio appears to be acceptable.


Eligibility criteria:
inclusion criteria healthy volunteers * normal ophthalmic findings, ametropia \< 3 dpt * men and women aged between 18 and 80 years exclusion criteria: any of the following will exclude a subject from the study: * participation in a clinical trial in the 3 weeks preceding the study * symptoms of a clinically relevant illness in the 3 weeks before the first study day * pregnancy

Keywords: retinal oxygenation retinal vessel diameters dynamic vessel analyzer (dva) oxymap t1
a phase 1 safety study of single and repeated doses of jsm6427 (intravitreal injection) to treat amd

Conditions: Macular Degeneration

Summary: the purpose of this study is to determine the way and rate that the study medication, jsm6427 a potent, highly specific integrin α5β1-antagonist is absorbed, broken-down and eliminated from the body when it is given as a single dosage strength by injection into the eye. repeated dosages will also be given to determine the highest safe dose.

in non-clinical models, jsm6427 can lead to the inhibition and regression of choroidal neovascularization, making α5β1 an attractive target for therapeutic strategies directed at pathological angiogenesis. jsm6427 may also interfere with other key processes in the pathogenesis of amd, namely inflammation and fibrosis. further, non-clinical data show that jsm6427 inhibits scarring and inflammation. thus, jsm6427 may target multiple important pathways in the pathogenesis of neovascular amd.

Eligibility criteria:
inclusion criteria: * best corrected visual acuity in the study eye between 5 and 7 letters inclusive using and etdrs chart (snellen equivalent of appx. 20/800 to 20/40. * subfoveal choroidal neovascularization (cnv) due to amd. * total area of the lesion (including blood, neovascularization and scar/atrophy) must be ≤ 12 da, of which at least 25% must be active cnv. * for patients with occult or non classic cnv; there must be the presence of subretinal hemorrhage (but still comprising no more than 50% of the lesion) and/or documented evidence of three or more lines of vision loss (etdrs or equivalent) during the previous 12 weeks. * clear ocular media and adequate pupillary dilatation to permit good stereo fundus photography for screening. * intraocular pressure of 21 mm hg or less. * retinal thickness ≥ 250 μm by oct. * normal screening erg * normal ecg exclusion criteria: * pdt within 120 days prior to screening in the study eye. * previous therapeutic radiation to the eye. * any retinovascular disease or retinal degeneration other than amd. * serous pigment epithelial detachment without the presence of neovascularization. * presence of pigment epithelial tears or rips. * previous posterior vitrectomy or retinal surgery. * any periocular infection in the past 4 weeks. * concomitant therapy with anti-vegf therapies, e.g. avastin, lucentis or macugen, or previous use of these agents within 60 days of screening in the study eye. * concomitant therapy with intravenous or intravitreous corticosteroids or use within 90 days of screening. * cataract surgery in the study eye within three months of screening. * intraocular surgery in the study eye within three months of screening. * presence of ocular infection in the study eye. * presence of severe myopia (-8 diopters or greater) in the study eye. * allergy to or prior significant adverse reaction to fluorescein. * any major surgical procedure within one month of trial entry.

Keywords: amd neovascular age-related macular degeneration
comparison of factor xii levels in gestational diabetic and healthy pregnancies

Conditions: Diabetic Pregnancy; Pregnancy Related; Complement System; Disorder

Summary: to compare factor xii levels in gestational diabetic and healthy pregnancies.

thirty singleton term pregnant women with a diagnosis of type i, type ii or gestational diabetes and thirty singleton uncomplicated term healthy pregnant women will be included in our study. our study will be performed at istanbul acibadem maslak hospital, turkey. blood will be drawn from each patient when they are hospitalized and before they deliver either vaginally or by cesarean section. blood will be drawn into two citrate tubes, each will contain 4 ml blood. blood will be transferred to the lab immediately and will be centrifuged. the supernatant will be stored at -80°c. when the anticipated number of samples are completed factor xii levels will be calculated in each sample.

Eligibility criteria:
inclusion criteria: * term pregnancy * pregnant patients with a diagnosis of type i diabetes * pregnant patients with a diagnosis of type ii diabetes * pregnant patients with a diagnosis of gestational diabetes * non-diabetic pregnancies * uncomplicated pregnancies exclusion criteria: * preterm pregnancy * postterm pregnancy * pregnant patients with a diagnosis of systemic diseases other than diabetes * complicated pregnancies

Keywords: diabetic pregnancies, factor xii
characterization of thyroid nodules using contrast enhanced ultrasound

Conditions: Thyroid Nodules

Summary: this study will evaluate thyroid nodules using specialized ultrasound imaging methods.


Eligibility criteria:
inclusion criteria: * 1. patients diagnosed with a thyroid nodule 2. age greater than or equal to 19 years of age 3. patients must sign informed consent exclusion criteria: * 1. women who are pregnant or nursing 2. patients with pulmonary hypertension, unstable cardiopulmonary condition,or right to left shunt 3. hypersensitivity to perfluten 4. psychological condition that renders the patient unable to understand the informed consent
long term evaluation of safety and efficacy of tildrakizumab in patients with psoriatic arthritis

Conditions: Psoriatic Arthritis

Summary: an open label phase 3 study

subjects from both inspire 1 (tild-19-07) and inspire 2 (tild-19-19) studies to roll over into this inspire lte study (tild-21-01).

Eligibility criteria:
inclusion criteria: * subjects possess the ability to understand the requirements of the study. * subject has provided written informed consent as evidenced by signature on an informed consent form approved by an institutional review board/ec. * agree to abide by the study restrictions, scheduled treatment, laboratory assessments, other study procedures and return to the site for the required assessments. * subject with psa who had met all eligibility criteria for the parent study, had completed the parent study treatment period and has not developed any parent protocol criteria for premature discontinuation of treatment or withdrawal from the study. exclusion criteria: * female subjects of childbearing potential who do not agree to abstain from heterosexual activity or practice a dual method of contraception. * female is pregnant or breastfeeding, or planning to become pregnant or initiate breastfeeding while enrolled in the study or up to 17 weeks after the last dose of imp. * subject has previously been enrolled in this long-term extension study. * any condition that in the opinion of the investigator represents an obstacle for study conduct and/or represents a potential unacceptable risk for the subject.
phase 3 study of oral ibrexafungerp (scy-078) vs. placebo in subjects with recurrent vulvovaginal candidiasis (vvc)

Conditions: Recurrent Vulvovaginal Candidiasis

Summary: this study is a phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of oral ibrexafungerp (formerly "scy-078") compared to placebo in female subjects 12 years and older with recurrent vvc (rvvc).

this study is a phase 3, multicenter, randomized, double-blind study to evaluate the efficacy and safety of oral ibrexafungerp (formerly "scy-078") compared to placebo in female subjects 12 years and older with rvvc. the primary objective of the study is to evaluate the efficacy of oral ibrexafungerp in preventing recurrences of vvc in subjects with rvvc based on clinical success. approximately 320 subjects are planned to be enrolled into the study. all subjects will receive treatment with oral fluconazole for their acute episode present at screening. subjects who respond to fluconazole for their acute episode will be enrolled in the prevention of recurrence phase of the study and randomized to ibrexafungerp or placebo. subjects who fail treatment with fluconazole for their acute episode will be included in a nested open label sub-study, in which they will be offered one-day oral ibrexafungerp for their unresolved acute episode.

Eligibility criteria:
key inclusion criteria: * diagnosis of symptomatic vvc with microscopic examination with koh positive for yeast and normal vaginal ph. * history of 3 or more episodes of vvc in the past 12 months. * culture confirmation and resolution of the signs and symptoms of the initial vvc episode (with treatment). * able to take oral tablets and capsules. key exclusion criteria: * vaginal conditions other than recurrent vvc that may interfere with the diagnosis or evaluation of response to therapy. * recent use of systemic and/or topical vaginal antifungal products. * pregnant. * history of major system organ disease.

Keywords: recurrent yeast infection recurrent yeast vaginitis chronic yeast vaginitis ibrexafungerp scy-078 rvvc
in vivo tice (transintestinal cholesterol excretion)

Conditions: Occlusion of Bile Duct With an External Bile Diversion.

Summary: so far, the liver has been the main target for cholesterol elimination. however, several recent studies performed in mice have described a new route of cholesterol excretion, the trans-intestinal cholesterol excretion or tice. tice allows direct elimination of plasma cholesterol in the feces directly via the intestine. until now, only indirect evidence suggests that tice is also active in humans, the goal of this proof of concept study is to provide the first proof of its existence in humans by using stable isotopes in patients with bile duct diversion.


Eligibility criteria:
inclusion criteria: - external bile duct diverted patients exclusion criteria: * inflammatory bowel disease * aphagia * renal or hepatocellular insufficiency * primary intestinal tumor * cholangitis or severe sepsis * acute or chronic diarrhea

Keywords: tice-human-stable isotopes
management and healthcare utilization of patients with chronic airway disease during the covid-19 epidemic

Conditions: Pulmonary Disease, Chronic Obstructive; Asthma

Summary: during the covid-19 epidemic, the medical treatment, disease status, and medication status of patients with chronic airway disease have not been studied. the purpose of this study is to investigate the management and healthcare utilization of patients with chronic airway disease and the influencing factors during the covid-19 epidemic.

during the covid-19 epidemic, the medical treatment, disease status, and medication status of patients with chronic airway disease have not been studied. the purpose of this study is to investigate the management and healthcare utilization of patients with chronic airway disease and the relevant factors during the covid-19 epidemic. using cross-sectional research methods, telephone interviews and questionnaire surveys were used to investigate the management and healthcare utilization of patients with chronic airway disease （copd and asthma）during the covid-19 epidemic.

Eligibility criteria:
inclusion criteria: * copd patients and asthma patients in the chronic airway disease database in peking university third hospital. exclusion criteria: * refusal to participate in this study; cognitive dysfunction.
depression in juvenile diabetics

Conditions: Depression; Diabetes Mellitus, Insulin-Dependent

Summary: depression is one of the most common emotional problems among youths with insulin dependent diabetes mellitus (iddm). it has been shown that depression in youths with iddm lasts a while and may have a role in later complications of the medical condition. and yet, there are no psychological interventions appropriate for such youngsters. the purpose of this study is to modify a treatment called ''contextual psychotherapy'' (that has been developed for depressed youngsters) in order to address special needs of depressed youths with iddm, and to ''pilot test'' the treatment. the youngsters to be recruited are those being cared for at the diabetes clinic of the children's hospital of pittsburgh. the treatment includes a 3- month phase (16 sessions), followed by a 3-month ''booster'' phase (3 sessions), and two later follow-up evaluations.


Eligibility criteria:
inclusion criteria: * iddm duration of less than 10 years * no major medical disorder other than iddm * no psychotropic medications * meets psychiatric diagnostic criteria for depression * parent and child willing to participate exclusion criteria: * does not live withing commuting distance * mental retardation

Keywords: depression
honey in chronic immune thrombocytopenia

Conditions: Chronic Thrombocytopenic Purpura

Summary: based on the assumption that honey may have an immunomodulatory effect, the aim of our present study will be to verify whether the intake of honey, as a natural substance, in patients with chronic immune thrombocytopenia (itp) could affect the platelet number and hence could affect the bleeding severity. thirty patients suffering from chronic itp will be recruited from the hematology clinic of the pediatric hospital of ain shams university, cairo, egypt. the diagnosis of itp will be based on the presence of isolated thrombocytopenia with a peripheral blood platelet count less than 100 x 109/l, and absence of any obvious initiating and/or underlying cause of the thrombocytopenia. chronic itp is defined as itp for at least 12 months. the age of the patients will range from 5 to 15 years, and they will be of both sexes. this study was approved by the local ethics committee of the pediatric department of ain shams university, and an informed consent to participate in this study will be obtained from at least one parent of each patient. furthermore, an ascent form will be obtained from each patient above 7 years of age.

study design: a crossover design (two 12-weeks intervention periods) will be used to measure treatment effects. the subjects will be randomized into two groups (intervention to control \[i/c\] and control to intervention \[c/i\] groups). each study group will have 15 subjects. the subjects in the i/c group will consume 2 ml honey/kg/dose (maximum 50 ml/dose), twice weekly in the first 12-week period (period 1) while the subjects in the c/i group will not receive honey as a control in period 1. after period 1 the subjects of each group will exchange their protocol for the following 12-week period (period 2). this design will allow the treatment effects to be measured between the study groups (namely between the different subjects) in the same study period, or period 1, as well as in the same subjects in a crossover comparison of periods 1 and 2.

Eligibility criteria:
inclusion criteria: 1. patients with chronic itp who did not receive any treatment specific for itp within the past 3 months 2. who did not receive bee honey or any medication that may affect platelet number or function within the past 3 months and 3. in whom the bleeding severity will range from 1 to 3 (mild to moderate bleeding) according to buchanan and adix (2002). exclusion criteria: 1. grade 4 bleeding severity, according buchanan and adix (2002) and 2. presence of diabetes mellitus.

Keywords: honey mucositis bee products